Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2018-06-30

Brief Summary

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Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.

The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.

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Detailed Description

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Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.

The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore 87 patients for each group are needed.

Conditions

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SBP Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cefotaxime

iv 2G q 8hrs for general, dose titration if needed (eg.CKD)

Group Type ACTIVE_COMPARATOR

Cefotaxime

Intervention Type DRUG

3 g

Ceftriaxone

iv 2G q 24hrs

Group Type EXPERIMENTAL

Ceftriaxone

Intervention Type DRUG

2 g

Ciprofloxacine

iv 400mg q 12hrs for general, dose titration if needed (eg.CKD)

Group Type EXPERIMENTAL

Ciprofloxacin

Intervention Type DRUG

400 mg

Interventions

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Cefotaxime

3 g

Intervention Type DRUG

Ceftriaxone

2 g

Intervention Type DRUG

Ciprofloxacin

400 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Liver cirrhosis patients with ascites
2. Ascitic fluid PMN cell count \>250/mm3
3. Age: 16\~70 years old

Exclusion Criteria

1. Allergic to 3rd generation cephalosporin or quinolone
2. Antibiotics within 2 weeks
3. Open abdominal surgery within 4 weeks
4. Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis
5. HCC with portal vein thrombosis
6. Pregnant woman
7. HIV positive

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No